Opportunity for Consultant in India TB Research Consortium at ICMR | Salary Rs 1,00,000/- per month
The Indian Council of Medical Research (ICMR), New Delhi, the apex body in India for the formulation, coordination and promotion of biomedical research, is one of the oldest medical research bodies in the world. As early as in 1911, the Government of India set up the Indian Research Fund Association (IRFA) with the specific objective of sponsoring and coordinating medical research in the country. After independence, several important changes were made in the organisation and the activities of the IRFA. It was redesignated in 1949 as the Indian Council of Medical Research (ICMR) with considerably expanded scope of functions.
For Project 'India TB Research Consortium'
Consultant (Data Management)
Essential Qualifications :
Professional with 1st class M.Sc (Bioinformatics / Statistics) B.tech (Bioinformatics / Statistics)/ M.Tech (Bioinformatics / Statistics) with strong Data Science background and 5 years of experience in core data management in clinical trials. Working knowledge of Clinical Database Development tools will be preferred
Professional with 2nd class M.Sc (Bioinformatics / Statistics / life sciences B.tech (Bioinformatics / Statistics) /M.Tech (Bioinformatics / Statistics) with Ph.D (Bio-Statistics) with strong Data Science background and 3 years of experience in core data management inclinical trials and Clinical Database Development.
Age Limited as on date : up to 70 years
• Doctorate in Bioinformatics or relevant subject from a recognized university.
• Additional Post-Doctoral research/2YRS teaching experience in Bioinformatics in recognized institute(s) after obtaining essential qualification
• Strong Knowledge of use of Bioinformatics tools.
• Ability to work on a number of projects in parallel
• Ability to work independently and as a pail of a team
• Close attention to detail, timelines and quality and Good planning and organization skills
• Thorough knowledge of ICH, GCP and regulatory requirements Or Well-versed in regulatory requirements for validation of data management systems, GCP, Good Clinical Data Management Practices (GCDMP)
• Excellent command of English, Good PC user knowledge, Proficient in Microsoft Office applications, internet, Email
• Sound understanding of the global drug development process
• Ability to develop/advise on training programs
• Familiarity with SAS programming
• Additional Experience preferred in various phases of clinical dials with full project life cycle experience (CRF design to database lock and reporting); use of commercial and/ or proprietary clinical data management systems, coding dictionaries/ encoding systems.
Nature of duties
1. Work on research projects under ITRC.
2. CRF development, CRF' annotation, database design and screen design and Database testing
3. Coding of medication, therapies and adverse events
4. Work flow development
5. Clinical Data Management.
6. Provide technical leadership, resource management and project management for the required technical aspects supporting CDM activities.
7. Provide inputs to ensure consistency and accuracy of Protocols, Study documentation Develop detailed data management plan, Data Validation manual, Data Handling Plans, Data Transfer Specification & eCRF for assigned trials.
8. Create and maintain Trial specific documents.
9. Act as the point of contact for 'The Clinical Trial Team in relation to all data management deliverables, issues and questions from trial teams and be responsible for resolutions.
10. Perform trial start up activities, including testing and edit check specifications for assigned trials.
11. Coordinate with Coders, Developers, to ensure that the project timelines and deliverable arc met consistently.
12. Coordinate with CRAs/project managers for timely resolution of queries.
13. Coordinate with the Database Programmers and Share service activity to ensure timely completion of activities and no backlog accumulated.
14. Performing independent review of data management deliverables following documented guidelines and also review data listings for consistency and accuracy of data.
15. Assist and guide team members in study conduct and close out activities like query management and locking activities.
16. Track study specific metrics and project forecasting and trends, as applicable.
17. Archive all necessary documents in study folder for audit purposes as per the timelines according to quality and security requirements.
18. Write edit specifications for the study
19. Create system configuration documents- Home page, System Settings, Rights and Roles
20. Manage project timelines, quality issues, resources, SOW (scope of work) / budget.
21. Actively Participate in Study Kick Off meetings and Clinical Trail Team meetings for the assigned trials ensuring appropriate level of support, Communication provided. 22. Development of data entry filling guidelines, data management ' plan, data validation plan/ edit checks documents and other DM related documentation .
23. Database validation Ensures 100 % execution of Quality Control (QC) testing and User Acceptance Testing (UAT)
24. Develop, review and maintain clinical databases
25. Data quality cheek, Query management and data merging and Ensures 100% clean data for safety and efficacy for the study.
26. Data Cleaning for study close out and perform all database lock proccduresand Report generation as and when required
27. Provide DM activities status to the team on daily basis
28. Write and review DM SOPs in accordance with GCP and 1CJ1 guidelines and develop associated training and competency testing
29. Maintain CRT's and database standards work in conjunction with clinical operations, clinical research and other operations to ensure accurate, efficient and complete data collection
30. Responsible for performing all aspects of DM process as related to processing and Quality Check of the data.
31. Ensures all DM procedures executed with a high attention to detail, accuracy and timelines
32. Frequent Travel to study sites for data related issues and trainings
Consolidated Emoluments : RS 1,00,000/- per month consolidated depending upon experience and knowledge
Tenure : One year
Syllabus for written examination : Degree level related to project work, if written test Conducted
Place of work : ICMR/DHR, New Delhi
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